Reference number
ISO 10993-23:2021
International Standard
ISO 10993-23:2021
Biological evaluation of medical devices — Part 23: Tests for irritation
Edition 1
2021-01
Preview
ISO 10993-23:2021
74151
недоступно на русском языке
Опубликовано (Версия 1, 2021)

ISO 10993-23:2021

ISO 10993-23:2021
74151
Язык
Формат
CHF 194
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Тезис

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.

This document includes:

— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

— details of in vitro and in vivo irritation test procedures;

— key factors for the interpretation of the results.

Общая информация

  •  : Опубликовано
     : 2021-01
     : 2021-02
    : Опубликование международного стандарта [60.60]
  •  : 1
  • ISO/TC 194
    11.100.20 
  • RSS обновления

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